The Treatment of Progressive Early Onset Spinal Deformities: A Multi-Center Outcome Study

Thoracic Insufficiency Syndrome Clinical Trial

— GSSG  

Official title:

The Treatment of Progressive Early Onset Spinal Deformities: A Multi-Center Outcome Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02299362
• Other study ID #: IRB-08055C
• Status: Completed
• Start date: October 2008
• Est. completion date: February 4, 2020

Study information

• Verified date: February 2020
• Source: Growing Spine Study Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to examine the treatment, both surgical and non-surgical, of patients with any form of early onset scoliosis. Such treatment may include the use of growth friendly devices that are surgically or magnetically lengthened; or the use of serial body casting or bracing, or observation. Outcomes examined will be what can be seen physically on the patient and on x-ray, as well as parent perception of how the treatment effects their child with the use of a health-related quality of life (HRQOL) questionnaire.

Description:

This multi-center study will evaluate the long-term clinical and radiographic outcomes of Early Onset Scoliosis (EOS) and other Early Onset Spinal and Chest Wall Deformities in a large population of patients.

The study will attempt to answer the following clinical questions:

1. How do clinical parameters (e.g. height, weight, pulmonary function, incidence of complications) differ between:

1. Age groups

2. Etiologic groups

3. Treatment types including operative and non-operative methods

4. Patients who receive definitive spinal fusion versus those who do not

2. How do radiographic parameters (e.g. curve size, spinal height, thoracic dimensions, sagittal profile, pelvic parameters, spinal balance) differ between:

1. Age groups

2. Etiologic groups

3. Treatment types including operative and non-operative methods

4. Patients who receive definitive spinal fusion versus those who do not

3. How does health-related quality of life (HRQOL), using the EOSQ-24 outcomes tool, differ between:

1. Age groups

2. Etiologic groups

3. Treatment types including operative and non-operative methods

4. Patients who receive definitive spinal fusion versus those who do not

4. What demographic, clinical, radiographic, and surgical factors contribute to the incidence of complications?

5. For patients with a particular diagnosis, age and/or treatment type, what are the clinical, radiographic and HRQOL changes before and after treatment?

6. What are the mechanisms that cause rod breakage in growing rod constructs? (This study question is a collaborative research study with the U.S. Food and Drug Administration).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2602
• Est. completion date: February 4, 2020
• Est. primary completion date: February 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Patients of any age and any diagnosis who undergo a growth-friendly surgical procedure, including but not limited to growing rods, VEPTR, Shilla, hybrid constructs, spinal tethering and staples

• Patients of any age and any diagnosis who undergo casting

• Patients of any diagnosis 10 years of age and younger who undergo spinal fusion of the thoracic and/or lumbar spine

• Patients of any diagnosis under 6 years of age with scoliosis curves of the thoracic and/or lumbar spine measuring > 25 degrees. Observed and braced patients included

Exclusion Criteria:

• Cervical spine anomalies alone will not be included

• Patient/family is unwilling to participate in the study

Related Conditions & MeSH terms

• Congenital Abnormalities
• Congenital Spinal Deformities
• Early Onset Scoliosis
• Infantile Idiopathic Scoliosis
• Neuromuscular Spinal Deformity
• Scoliosis
• Syndromic Spinal Deformity
• Thoracic Insufficiency Syndrome

Locations

Country	Name	City	State
Canada	Hospital Sainte-Justine	Montreal	Quebec
Canada	British Columbia Children's Hospital	Vancouver	British Columbia
Egypt	Cairo University	Giza
Ghana	FOCOS Orthopaedic Hospital	Accra	Pantang West
Spain	Hospital Unversitario La Paz	Madrid
Spain	Hospitales Unversitarios Virgen del Rocio	Sevilla
Turkey	Hacettepe University	Ankara
United Kingdom	Royal Orthopaedic Hospital	Birmingham
United States	C.S. Mott Childrens Hospital	Ann Arbor	Michigan
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Children's Hospital Boston	Boston	Massachusetts
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	Texas Scottish Rite Hospital for Children	Dallas	Texas
United States	University of Florida	Gainesville	Florida
United States	Texas Children's Hospital	Houston	Texas
United States	Indiana University Riley Hospital for Children	Indianapolis	Indiana
United States	Children's Mercy Kansas City	Kansas City	Missouri
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Hospital for Special Surgery	New York	New York
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of Rochester	Rochester	New York
United States	Washington University	Saint Louis	Missouri
United States	Rady Children's Hospital	San Diego	California
United States	Children's National Medical Center	Washington	District of Columbia
United States	Nemours/Alfred I. Dupont Hospital for Children	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Growing Spine Study Group	Growing Spine Foundation

Countries where clinical trial is conducted

United States,  Canada,  Egypt,  Ghana,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical and Radiographic	Evaluation of long-term clinical measures such as: BMI, Pulmonary functionality, incidence of complications; and radiographic outcomes (e.g. coronal spinal curvature, sagittal profile, spinal and thoracic growth, coronal and sagittal alignment.	18 years
Secondary	Patient based outcomes	Evaluation of the effect of treatment on patients and families by use of serial early-onset scoliosis questionnaire (EOSQ-24) scores during treatment. EOSQ covers the following domains: Child's Health Related Quality of Life (16 items), Family Impact (2 items) and Satisfaction (2 items).	18 years

External Links

•   Growing Spine Foundation webpage